New Antiepileptic Drug Option for People with Difficult To Control Epilepsy

05/17/2011

GlaxoSmithKline has today launched Trobalt® (retigabine), the first in a new class of anti-epileptic drug (AED), for the adjunct treatment of adults with partial-onset seizures, and demonstrated significant effects in a treatment resistant patient population.1

Retigabine is the first and currently only AED to target neuronal potassium channels1 which are involved in inhibitory mechanisms in the brain, and are thought to have a role in seizure control.2,3

"Epilepsy is a common disorder that can affect the very young, the elderly and all ages in between. When uncontrolled, it is associated with substantial limitations to quality of life, an increased risk of sudden death and significant costs to the affected individual, to society and to the healthcare system. Trobalt represents a positive addition to the therapeutic armamentarium for the many adult patients with inadequately-controlled focal onset seizures."

The efficacy and safety of retigabine was established in two pivotal multicentre, randomised, double-blind, placebo-controlled, fixed dose studies - RESTORE 1 and 2 (Retigabine Efficacy and Safety Trials for Partial Onset Epilepsy) where patients who were treatment resistant were recruited.4,5 Retigabine significantly improved seizure control, with a greater number of patients achieving a reduction in the number of seizures by 50% or more, compared with placebo.4,5

It is thought that of those people diagnosed with epilepsy in the UK, around 30 percent do not respond to initial AED treatments and remain uncontrolled. This group is considered treatment resistant6 and equates to approximately 60,000 people in the UK.7-13

Retigabine, referred to as ezogabine in the US, is being jointly developed by GSK and Valeant.

Notes

About retigabine

Retigabine is a first-in-class antiepileptic drug acting on the specific Kv7 potassium channels as adjunct treatment for partial-onset epilepsy.1

To date, retigabine has been tested in 1365 patients across all phase I, II and III studies.4,5 Phase III studies for retigabine demonstrated significantly improved seizure control, with a greater number of patients achieving a reduction in the number of seizures by 50% or more, compared with placebo.4,5

About epilepsy

Epilepsy is a neurological condition that affects 456,000 people in the UK,14 resulting in brief disturbances in the normal electrical signals of the brain. Partial seizures, which affect part of the brain, are the most common type of seizure experienced by people with epilepsy. Difficult to control/drug resistant epilepsy refers to people who still experience seizures despite taking medication. Currently 30% of those suffering from epilepsy experience this.6

Most non-elective (emergency) epilepsy hospital admissions are due to seizures.15 In 2007-08, epilepsy was responsible for 51,864 episodes of patient care, accounting for 151,007 occupied bed days.15 In the period of 1993-2000, there were about 800 deaths per year where epilepsy was the underlying cause and about 37,000 admissions where epilepsy was the main diagnosis.16